18 and older, any sex, with HIV Infection or Alcohol Use. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Medication Tolerability Measured Via a 0-100 Visual Analog ScalePrimary· Primary endpoint at 8 weeks
Medication tolerability will be measured via a 0-100 visual analog scale. Participants will be asked to indicate on a scale of 0-100, how well they have tolerated the study medication with 0 anchored as "cannot tolerate at all" and 100 as "tolerate perfectly well." Higher numbers will be indicative of higher tolerability of the medication.
Group
Value
95% CI
Low Dose Naltrexone
90.7
± 22.4
Nalmefene
NA
± NA
Change in Alcohol Use Defined as a Change in the Mean Number of Grams of Pure Ethanol Consumed Per Day From Baseline to 8 WeeksSecondary· Baseline, 8 weeks
Measured via 30 Day Alcohol Use Timeline Follow Back Method
Group
Value
95% CI
Low Dose Naltrexone
5.5
± 10.1
Nalmefene
-6.83
± 9.7
Treatment Discontinuation Defined as Patient Self-report of Stopping Medication Anytime During the Treatment PeriodSecondary· 4 weeks, 8 weeks
Measured via one question asking participants if they had discontinued medication since their last visit. Assessed at 4 and 8 week study visits.
4-Weeks
Group
Value
95% CI
Low Dose Naltrexone
1
Nalmefene
1
8-Weeks
Group
Value
95% CI
Low Dose Naltrexone
1
Nalmefene
2
Adherence to Medication Defined as Self-report of Percentage of Study Medication Taken in the Past Two WeeksSecondary· Endpoint at 8 weeks
Measured by participants' drawing a line on a a Visual Analog Scale, which ranges from 0 to 100. Higher numbers indicate higher adherence to study medication.
Group
Value
95% CI
Low Dose Naltrexone
87.5
± 35.4
Nalmefene
0
± 0
Number of Participants With Adherence Assessed Via Riboflavin in the Urine Confirming AdherenceSecondary· Endpoint at 8 weeks
Measured through visual inspection of the urine for the presence or absence of riboflavin using ultraviolet (UV) light at the long wave setting (33 mm) in a room with low ambient light.
Group
Value
95% CI
Low Dose Naltrexone
1
Nalmefene
0
Reported Side Effects Using a Symptom Checklist, Plus an Open-ended QuestionSecondary· 2 weeks, 4 weeks, 6 weeks, 8 weeks
Measured via a 16-item symptom checklist with the option for participants to report any experienced side effects not on the checklist. Side effect severity is rated by trained research assessors. The checklist is asked at 2, 4, 6, and 8-week study visits.
2-Weeks
Group
Value
95% CI
Low Dose Naltrexone
1.5
± 1.6
Nalmefene
4.5
± 6.4
4-Weeks
Group
Value
95% CI
Low Dose Naltrexone
1.3
± 1.2
Nalmefene
1.5
± 2.1
6-Weeks
Group
Value
95% CI
Low Dose Naltrexone
0.9
± 1.0
Nalmefene
1.5
± 2.1
8-Weeks
Group
Value
95% CI
Low Dose Naltrexone
0
± 0
Nalmefene
0
± 0
Medication Satisfaction Defined as a Score From 0-100 Measured Via the Treatment Satisfaction Questionnaire for Medication (TSQM), With Higher Scores Corresponding to Higher Treatment Satisfaction.Secondary· 4 weeks, 8 weeks
Measured via using the 14-item Treatment Satisfaction Questionnaire, which consists of 14 items that result in four domains: Effectiveness, Side Effects, Convenience and Global Satisfaction. Higher scores indicate greater satisfaction with medication. Assessed at 4 and 8 week study visits.
4-Weeks
Group
Value
95% CI
Low Dose Naltrexone
47.3
± 24.4
Nalmefene
3.6
± 5.1
8-Weeks
Group
Value
95% CI
Low Dose Naltrexone
47.3
± 21.9
Nalmefene
3.6
± 5.1
Severe Hepatotoxicity Defined as AST/ALT >10X the Level of NormalSecondary· Endpoint at 8 weeks
Aminotransferase levels (AST/ALT) are tested to look for severe hepatotoxicity defined as AST/ALT \> 10 times the level of normal.
Group
Value
95% CI
Low Dose Naltrexone
0
Nalmefene
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data were collected over the course of the 8-week treatment period..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study is a randomized controlled trial (RCT) to assess the feasibility, tolerability, and safety of using opioid receptor antagonists (naltrexone and nalmefene) to treat pain among HIV-infected persons with heavy alcohol use and chronic pain.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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· recruiting
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· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boston Medical Center
Last refreshed: 24 August 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03278886.